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A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease (NCT03026231)

Kelsey Research Foundation
The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.
  • Biological: PRIM-DJ2727
    Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules
    • Drug: Placebo (for PRIM-DJ2727)
      Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
      Ages eligible for Study
      45 Years to 70 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Diagnosis PD with a Hoehn and Yahr stage of < 3 in the "Off medicine" state
      • Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
      • Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
      • Subject willing to sign an informed consent form
      • Subject deemed likely to survive for ≥ 1 year after enrolment
      • Subject's attending physician will refer and provide non-transplant care for the subject
      • Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study.
      Exclusion Criteria:
      • Greater than 20 grams of ethanol intake daily
      • Unstable Parkinson's disease
      • Other immune disorder or clinical immunosuppression
      • Probiotic used during study period
      • Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments
      • Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria
      • Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy
      • HIV or Hepatitis B / C positive

      1 locations

      United States (1)
      • The University of Texas Health Science Center at Housotn
        not yet recruiting
        Houston, Texas, United States, 77030
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      Ⅰ, Ⅱ
      Start:
      14 July, 2017
      Updated:
      17 April, 2017
      Participants:
      30
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